Objectives: This study aims to examine the impact of European Union (EU) law relating to information technology (IT) on health systems.

Methods: The study identifies EU directives relating to IT, analyzes them in terms of their impact on the use of IT in health systems, and outlines their implications for health technology assessment (HTA). Analysis is based on a review of literature identified through relevant databases and Internet searches.

Results: Developments in IT have serious implications for EU health systems, presenting policy makers with new challenges. The European Commission has adopted a range of legal measures to protect consumers in the “information society” However, as few of them are health-specific, it is not evident that they have implications for health, health systems, or HTA, and they may not be effective in protecting consumers in the health sector.

Conclusions: In light of the growing importance of IT in the health sector, legal and nonlegal measures need to be further developed at EU and international level. Where possible, future initiatives should pay attention to the particular characteristics of health goods and services and health systems. Although definitions of HTA usually recognize the importance of evaluating both the indirect, unintended consequences of health technologies and the legal aspects of their application, it seems that, in practice, HTA often overlooks or underestimates legislative matters. Those involved in HTA should be aware of the legal implications of using IT to provide health goods and services and compile, store, transfer, and disseminate health information electronically.

Objectives: The clinical assessment efficiency of the CAGE questionnaire for alcohol abuse based on diagnostic accuracy has not been fully established to date because of the varied and inconclusive gold standards used as diagnostic criteria. CAGE has also been highlighted to miss almost half of the risk-drinkers due to the use of inadequetly set criteria for the positive recognition of alcohol abuse. This study aims to establish the diagnostic accuracy of CAGE at different treatment settings.

Methods: A hybrid of the receiver operating characteristic (ROC) and the Taguchi method was used, as this approach proved to evaluate the diagnostic performance and accuracy in hypothetical clinical settings. Data were used from three cross-clinical treatment settings, i.e., general medicine outpatients, medical inpatients, and psychiatric inpatients, and analyzed by means of a step-wise application of managable number of statistical indices such as the area under the ROC curve (AUC), leveling factor (p′), and signal-to-noise ratios (S/N; standardized S/N [SS/N]).

Results: The selected settings yielded similar AUCs but portrayed different trade-offs on the ROC curves signaling the presence of different critical CAGE scores. Analysis of the sensitivity and specificity data of i, ii, iii by p′, S/N, SS/N and their dependent relation resulted in the critical CAGE scores of 1,1, and 2; and high diagnostic accuracy levels of 76.84 percent, 86 percent, and 76.84 percent, respectively.

Conclusions: By setting these critical CAGE scores as the minimum detection levels of alcohol abuse, early intervention before the onset of serious alcohol-related problems is possible. This will decrease the health-care costs of the patient and, in addition, reduce the psychological and social burdens inherent to alcohol abuse both on the patient and society. Having its critical scores reliably identified and diagnostic accuracy fully determined, CAGE can now improve the detection rate of problem drinking individuals substantially.

Objectives: The objective of the study was to estimate the costs and health benefits of a public awareness campaign aimed at shortening the delay for thrombolytic therapy in patients with acute myocardial infarction (AMI) and to estimate the incremental costs and benefits of an additional telemedicine program.

Methods and Results: By using trial data on the impact of a Swedish campaign, a model was developed to simulate the current distribution of thrombolytic delay in Denmark and the delay after a campaign. The reduction in delay was translated into reduced fatality assuming reductions from the campaign and additional effects of a telemedicine program. The costs of the campaign were based on trial data and Danish unit costs while telemedicine costs were taken from a Danish demonstration program. The analyses indicate that the awareness campaign will translate into five fewer fatal AMIs (sixty-two life years gained) and a cost per life year of DKK283,300, with both costs and benefits discounted at 5 percent. When combining the public campaign with prehospital telemedicine diagnostics, the incremental cost per life year gained was DKK854.700.

Conclusions: Programs aimed at reducing delay of thrombolysis in patients with AMI are likely to have a limited impact on AMI fatality. Information campaigns may have acceptable cost-effectiveness ratios, while telemedicine programs lead to threefold greater ratios. Whether such programs can be considered cost-effective will depend on how life year gains are valued by society.

Objectives: This study tested the reliability and validity of the Western Canada Waiting List Project priority criteria score (PCS) for prioritizing patients waiting for hip and knee arthroplasty.

Methods: Sixteen orthopedic surgeons assessed 233 consecutive patients at consultation for hip or knee arthroplasty. Measures included the PCS, a visual analogue scale of urgency (VAS urgency), and maximum acceptable waiting time (MAWT). Patients completed a VAS urgency, an MAWT, the Western Ontario McMaster Osteoarthritis Index (WOMAC), and the EQ-5D. Using correlational analysis, convergent and discriminant validity was assessed between similar constructs in the priority criteria and WOMAC. Median MAWTs were determined for five levels of urgency based on PCS percentiles. Internal consistency reliability was assessed with Cronbach's alpha.

Results: The sample of 233 patients (62 percent female) ranged in age from 18 to 89 years (mean, 66.3 years). A total of 45 percent were booked for hip and 55 percent for knee arthroplasty. Correlations were strong between the PCS and surgeon VAS urgency (r=.79) and weaker between patient and surgeon measures of VAS urgency (r=.24) and MAWT (r=.44). Correlation coefficients between similar constructs in the priority criteria and WOMAC ranged from 0.24 to 0.32 and were higher than those measuring dissimilar constructs. For decreasing levels of urgency, the median MAWT ranged from 10 to 12 weeks for surgeons and 4 to 12 weeks for patients. Cronbach's alpha was 0.79.

Conclusions: Results support the validity of the PCS as a measure of surgeon-rated urgency. Patients might be ranked differently with different prioritization measures.

Objectives: To estimate the excess cost of stroke in Sweden and the potential costs that could be avoided by preventing first-ever strokes.

Methods: We adopted the incidence approach for estimating the present value of both direct and indirect costs. Data on mortality, stroke recurrence, and inpatient care were estimated from a national register of patient data with a four-year follow-up period. To estimate costs for social services, we used survey data on living conditions before stroke onset and at three and at twenty-four months. Costs for outpatient visits, rehabilitation, drugs, and production losses due to premature death and early retirement were estimated on the basis of both published and nonpublished sources. Lifetime costs were based on life tables adjusted for excess mortality of stroke, and costs in year 4 were extrapolated to subsequent years.

Results: The present value direct cost for an average stroke patient is SEK513,800 (US$56,024 or Euro60,825). The corresponding indirect cost is SEK125,110 (US$13,640 or Euro14,810). Almost 45 percent of the direct costs were attributable to social services. Women had higher costs than men, and costs for survivors increased with age due to social services.

Conclusions: With an incidence of 213 first-ever strokes per 100,000 individuals, the total excess direct and indirect cost of stroke would be SEK12.3 billion (approximately US$1.3 billion or Euro1.5 billion). Hence, there are large potential cost offsets both in the health-care sector and in the social service sector if the incidence of first-ever stroke could be reduced.

Objectives: The research question was whether training level of admitting physicians and referrals from practitioners in primary health care (PHC) are risk factors for emergency readmission within 30 days to internal medicine.

Methods: This report is a prospective multicenter study carried out during 1 month in 1997 in seven departments of internal medicine in the County of Stockholm, Sweden. Two of the units were at university hospitals, three at county hospitals and two in district hospitals. The study area is metropolitan–suburban with 1,762,924 residents. Data were analyzed by multiple logistic regression.

Results: A total of 5,131 admissions, thereby 408 unplanned readmissions (8 percent) were registered (69.8 percent of 7,348 true inpatient episodes). The risk of emergency readmission increased with patient's age and independently 1.40 times (95 percent confidence interval [CI], 1.13–1.74) when residents decided on hospitalization. Congestive heart failure as primary or comorbid condition was the main reason for unplanned readmission. Referrals from PHC were associated with risk decrease (odds ratio, 0.53; 95 percent CI, 0.38–0.73).

Conclusion: The causes of unplanned hospital readmissions are mixed. Patient contact with primary health care appears to reduce the recurrence. In addition to the diagnoses of cardiac failure, training level of admitting physicians in emergency departments was an independent risk factor for early readmission. Our conclusion is that it is cost-effective to have all decisions on admission to hospital care confirmed by senior doctors. Inappropriate selection of patients to inpatient care contributes to poor patient outcomes and reduces cost-effectiveness and quality of care.

Objectives: Early warning systems are an integral part of many health technology assessment programs. Despite this finding, to date, there have been no quantitative evaluations of the accuracy of predictions made by these systems. We report a study evaluating the accuracy of predictions made by the main United Kingdom early warning system.

Methods: As prediction of impact is analogous to diagnosis, a method normally applied to determine the accuracy of diagnostic tests was used. The sensitivity, specificity, and predictive values of the National Horizon Scanning Centre's prediction methods were estimated with reference to an (imperfect) gold standard, that is, expert opinion of impact 3 to 5 years after prediction.

Results: The sensitivity of predictions was 71 percent (95 percent confidence interval [CI], 0.36–0.92), and the specificity was 73 percent (95 percent CI, 0.64–0.8). The negative predictive value was 98 percent (95 percent CI, 0.92–0.99), and the positive predictive value was 14 percent (95 percent CI, 0.06–0.3).

Conclusions: Forecasting is difficult, but the results suggest that this early warning system's predictions have an acceptable level of accuracy. However, there are caveats. The first is that early warning systems may themselves reduce the impact of a technology, as helping to control adoption and diffusion is their main purpose. The second is that the use of an imperfect gold standard may bias the results. As early warning systems are viewed as an increasingly important component of health technology assessment and decision making, their outcomes must be evaluated. The method used here should be investigated further and the accuracy of other early warning systems explored.

Objectives: The purpose of this study is to describe the situation with the distribution and utilization of prenatal diagnosis technology in China, to identify some important barriers to prenatal diagnosis use, and to suggest changes to improve the present situation.

Methods: The study uses cross-sectional surveys to capture quantitative data from both providers and consumers. Qualitative information based on focus group discussions is also presented.

Results: A mail survey of the provincial Bureaus of Health (BOHs) reveals that sixteen provincial prenatal diagnosis centers and twelve city level centers were accredited by the BOHs by July of 2001. These centers were located in thirteen provinces, of thirty in all of China. Of 147 selected institutions surveyed separately, 90.5 ercent offer ultrasound examination, 72.1 percent provide pathogen tests (mainly Toxoplasma, rubella virus, cytomegalovirus, and herpes simplex or TORCH), 57.1 percent do biochemical tests, 21.8 percent have genetic counseling, 13.6 percent do karyotype testing, 7.5 percent do enzymology testing, and 5.4 percent carry out molecular genetic testing. Chromosome diseases, congenital diseases, and several gene diseases are the target diseases. According to qualitative data, macromanagement for prenatal diagnosis, supplier provision of tests, and population demand are the main influences on prenatal diagnosis use.

Conclusions: From the quantitative and qualitative analysis, it is clear that the technology of prenatal diagnosis is not diffusing well throughout China and is apparently not appropriately used. The situation of prenatal diagnosis has implications for policy-makers, including identification of priorities, regulation of prenatal diagnosis, strategic planning, development of guidelines based on health technology assessment, and consumer orientation.

Objectives: Hospital readmission rate is currently used as a quality of care indicator, although its validity has not been established. Our aims were to identify the frequency and characteristics of potential avoidable readmissions and to compare the assessment of quality of care derived from readmission rate with other measure of quality (judgment of experts).

Methods: Design: cross-sectional observational study; Setting: acute care hospital located in Marbella, South of Spain; Study participants: random sample of patients readmitted at the hospital within six months from discharge (n=363); Interventions: review of clinical records by a pair of observers to assess the causes of readmissions and their potential avoidability; Main measures: logistic regression analysis to identify the variables from the databases of hospital discharges which are related to avoidability of readmissions. Determination of sensitivity and specificity of different definitions of readmission rate to detect avoidable situations.

Results: Nineteen percent of readmissions were considered potentially avoidable. Variables related to readmission avoidability were (i) time elapsed between index admission and readmission and (ii) difference in diagnoses of both episodes. None of the definitions of readmission rate used in this study provided adequate values of sensitivity and specificity in the identification of potentially avoidable readmissions.

Conclusions: Most readmissions in our hospital were unavoidable. Thus, readmission rate might not be considered a valid indicator of quality of care.

Designing & Conducting Cost-Effectiveness Analyses in Medicine and Health Care by Muennig P and contributing editor Khan K. San Francisco: Jossey-Bass, John Wiley & Sons, Inc; 2002, 356 pp., UK £48.50, hardbound.

Reviewed by: Wija Oortwijn, PhD and Eddy Adang, PhD, University Medical Centre Nijmegen, Department of HTA, Nijmegen, The Netherlands.

Objectives: To describe the adoption and take up of thrombolytic agents for acute myocardial infarction since 1980 in England and compare use with the estimated ceiling of need.

Methods: Data on national sales and use of thrombolysis since 1980 (supplied by IMS Health) was used to draw an adoption and diffusion curve. The epidemiological ceiling of acute myocardial infarction, from hospital activity statistics, was modified to an estimated clinical need by accounting for diagnostic difficulty and contraindications using information from published surveys of thrombolysis use in the United Kingdom.

Results: There was a rapid uptake of thrombolytic agents in the first 2 years after availability in 1987, then a plateau, followed by a rise to a peak use in 1995. The shortfall in doses resulting from the difference between estimated ceiling of clinical need and doses purchased and provided in the 14 years since availability is estimated as 167,800 (95 percent confidence range 94,000 to 241,700).

Conclusions: Although there was a rapid initial uptake of thrombolysis in England, usage took 8 years to reach the ceiling of clinical need of 65 percent of patients with acute myocardial infarction, with many patients missing the opportunity to benefit. Monitoring of uptake of innovations known to be cost-effective is required to identify those developments that need additional stimulus for change to ensure that patients do not miss out on the opportunity to benefit.

David B. Evans of the World Health Organization was erroneously omitted from the list of authors of the article entitled “Cost-effectiveness analysis: Can we reduce variability in costing methods,” which was published in Volume 19 Number 2 (Spring 2003) of International Journal of Technology Assessment in Health Care. We regret the oversight.

Objectives: To investigate the factors that influenced the adoption and diffusion of thrombolysis in acute myocardial infarction in England and to verify usage data from 1981 to 2001.

Methods: Survey of cardiologists in England using a pre-prepared time line of historical events and a plot of thrombolysis diffusion since 1981. The cardiologists were divided into three groups that were provided with (i) the time line only, (ii) the diffusion curve only, and (iii) the time line and the diffusion curve.

Results: The GISSI and ISIS-2 clinical trials were perceived to have had a significant influence upon the initial diffusion of thrombolysis in England occurring over the 3 years after launch. Other positive influences included the initial listing in the national formulary, the change to administration in emergency departments, the rise in evidence-based medicine, and production of national guidance.

Conclusions: Although it is apparent that the overall influences on adoption and diffusion of thrombolysis were multiple; clinical trials, service developments, and national guidelines all were judged to have played a part. The GISSI and ISIS-2 clinical trials were confirmed as the major influence on initial adoption.

Purpose: To estimate the benefit and cost of using radiotherapy (RT) in the initial management of lung cancer in the general population.

Methods: We identified indications for RT in the initial management of small cell and non–small cell lung cancer through a review of the literature. The proportion of patients with each specific indication for treatment was determined using epidemiological observations from cancer registry data and from the literature. We estimated the benefit gained from RT use for each indication in the model using values published in the literature. We estimated the cost of RT for each indication using published Canadian data. The total benefit and cost was calculated for all indications combined. Results are reported in 2001 Canadian dollars.

Results: The mean benefit was 7 months of survival for each lung cancer patient treated with curative intent and 3 months of symptom control for each patient treated with palliative intent. The average cost was $9,881 per life year gained and $13,938 per year of symptom control gained. Sensitivity analysis revealed values between $7,905 and $19,762 per year of survival gain and between $10,368 and $27,875 per year of symptom control gained.

Conclusions: Using RT in the initial management of lung cancer can provide considerable gains in survival and symptom control. The cost of RT for the initial management of lung cancer is inexpensive compared with a common cut off of $50,000 per life year gained.

Jiju Antony, BEng, MEngSC, PhD, MIQA, MASQ, Division of Management, Caledonian Business School, Glasgow Caledonian University, Glasgow, UK

Objectives: This study proposes the method requirements for a valid costing study in anesthesia to allow differences to be identified between treatments and uses these method requirements to design and conduct a robust costing study.

Methods: A prospective, patient-based costing study was carried out in adult and pediatric day surgery in the United Kingdom. The perspective was that of the National Health Service and the patient. Data were collected for each patient until 7 days after hospital discharge.

Results: Data were collected for 1,063 adults and 322 children undergoing day surgery between October 1999 and January 2001. Statistically significant differences were found only between variable costs, which accounted for 11.4 percent and 9.0 percent of adult and pediatric costs, respectively. There were no differences in length of stay, fixed costs, or semi-fixed costs. Differences were not found in total costs in adults but were found in children. By day 7, postdischarge primary and secondary care costs were not different between groups in either study. No differences were found in costs to patients or parents.

Conclusions: The use of prospective, patient-based cost data enabled the detection of differences in variable costs between difference anesthetic regimens in day surgery. The stochastic nature of the data provided a measure of variability around mean cost estimates. Practice patterns in the study reflected normal practice in the United Kingdom so the costing data have direct clinical relevance. The use of different anesthetic agents only affected variable costs and had no effect on larger cost drivers such as length of stay or staff input.

Treating and Preventing Obesity. An Evidence Based Review by The Swedish Council on Technology Assessment in Health Care (Östman J, Britton M, Jonsson E, eds). Weinheim: Wiley-VCH, 2004.

Reviewed by: Jarl S Torgerson, Sahlgrenska University Hospital, Göteborg, Sweden.

References 8, 29, and 32 are incorrect as they appear in the article entitled “Technology assessment, priority setting, and appropriate care in Dutch health care,” by Marc Berg, Tom van der Grinten, and Niek Klazinga (Int J Technol Assess Health Care. 2004;20[1]:35-43). They should appear as follows: 8. Burgers JS, Bailey JV, Klazinga NS, et al. Inside guidelines: comparative analysis of recommendations and evidence in diabetes guidelines from 13 countries. Diabetes Care 2002;11:1933-1939.29. Zwart-van Rijkom JE, Leufkens HG, Busschbach JJ, et al. Differences in attitudes, knowledge and use of economic evaluations in decision-making in The Netherlands. The Dutch results from the EUROMET Project. Pharmacoeconomics 2000;2:149-160.32. Van der Grinten TED. Hervorming van de gezondheidszorg. Zal het deze keer wel lukken? Beleid & Maatschappij 2002;3:172-176.

Grazyna T. Adamiak, MA, MPH&W, PhD, Department of Public Health and Caring Sciences, Section of Health Services Research, Uppsala University, Dag Hammarskölds väg 14B, 751 85 Uppsala, Sweden; e-mail: g.adamiak@telia.com